(101 days)
No
The summary describes a computerized electromechanical device for transcranial magnetic stimulation, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the "treatment of Major Depressive Disorder," which signifies a therapeutic purpose.
No
The device is described as a "tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder," indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states that the NeuroStar TMS Therapy System is an "integrated system consisting of a combination of hardware, software, accessories and consumable supplies." It details various hardware components like a Mobile Console, gantry, Treatment Coil, Head Support System, and SenStar Connect. Performance studies also include hardware testing.
Based on the provided information, the NeuroStar TMS Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- NeuroStar Function: The NeuroStar TMS Therapy System is a therapeutic device that directly interacts with the patient's body (applying magnetic stimulation to the cerebral cortex) for treatment purposes. It does not analyze biological samples.
- Intended Use: The intended use is for the treatment of Major Depressive Disorder, not for diagnosis or analysis of biological samples.
- Device Description: The description details a system that delivers magnetic pulses to the head, not a system for analyzing biological specimens.
Therefore, the NeuroStar TMS Therapy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Product codes
OBP
Device Description
The NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec nominal) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. NeuroStar TMS Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers NeuroStar TMS Therapy®. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. The SenStar Connect is a non-sterile, multi-use consumable which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment and provides surface field cancellation to reduce stimulation of the scalp. The TMS TrakStar™ practice data management system consists of a standalone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral cortex
Indicated Patient Age Range
adult patients
Intended User / Care Setting
licensed physician; inpatient and outpatient settings including physician's offices and clinics, and hospitals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance Testing:
The following performance tests were conducted to demonstrate the substantial equivalence of NeuroStar 3.0 to the predicate NeuroStar TMS Therapy System.
- Magnetic field mapping in 3-dimensions, spatial and temporal characteristics, and pulse sequence timing
- Coil positioning accuracy for MT, MT level and treatment location
The following additional tests were conducted to demonstrate that NeuroStar 3.0 meets performance specifications.
- NeuroStar system hardware and software unit, system and user story testing
- Usability engineering testing
- Electrical safety testing to IEC 60601-1:2005 and Electromechanical Compatibility (EMC) testing to IEC 60601-1-2:2007, Third Edition
Verification and validation testing demonstrated that the changes to NeuroStar 3.0 do not substantially modify the performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2016
Neuronetics, Inc. Judy Ways, Ph.D. V.P., Regulatory Affairs and Quality Assurance 3222 Phoenixville Pike Malvern, Pennsylvania 19355
Re: K161519
Trade/Device Name: Neurostar TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: August 12, 2016 Received: August 15, 2016
Dear Dr. Ways:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
William J. Heetderks -A
342 19200300 100 1 1-0010149843
for Carlos L. Peña. PhD. MS
Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161519
Device Name NeuroStar® TMS Therapy System
Indications for Use (Describe)
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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NEURONETICS
510(k) Summary
NeuroStar® TMS Therapy System
| 510(k) Owner: | Neuronetics, Inc.
3222 Phoenixville Pike
Malvern, PA 19355
Phone: 610-640-4202
Fax: 610-640-4206 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Judy P. Ways, Ph.D.
Vice President,
Regulatory Affairs and Quality Assurance
Neuronetics, Inc.
3222 Phoenixville Pike
Malvern, PA 19355
Phone: 610-981-4107
Fax: 610-640-4206 |
| Date Prepared: | 12 August 2016 |
| Proprietary Name: | NeuroStar® TMS Therapy System |
| Common Name: | Transcranial Magnetic Stimulator |
| Classification
Name: | Transcranial Magnetic Stimulator for Treatment of Major
Depressive Disorder [21 CFR 882.5805, Product Code OBE |
| Predicate Device: | NeuroStar TMS Therapy® System [K133408] |
Device Description:
The NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec nominal) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. NeuroStar TMS Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar System
4
is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers NeuroStar TMS Therapy®. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. The SenStar Connect is a non-sterile, multi-use consumable which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment and provides surface field cancellation to reduce stimulation of the scalp. The TMS TrakStar™ practice data management system consists of a standalone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.
Indication/Intended Use:
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Technological Characteristics and Substantial Equivalence:
The NeuroStar TMS Therapy System 3.0 is substantially equivalent to the predicate device (NeuroStar TMS Therapy System, K133408, K160703) for:
- Indication for Use ●
- Principles of Operation
- Design for Delivery of Transcranial Magnetic Stimulation .
- . Performance Specifications
- Materials ●
- Standards ●
The NeuroStar TMS Therapy System 3.0 modifications from the predicate device include enhanced thermal performance of the system, improved ergonomics and reliability in handling of the Treatment Coil, and an improved user work flow for the recording of treatment information to the NeuroStar software. Software password security has been enhanced in NeuroStar 3.0 and the TrakStar data management system.
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| Device Feature | NeuroStar TMS System
(K133408) | NeuroStar TMS Therapy
System 3.0 |
|--------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Treatment Level Range | 0.22 SMT to 2.11 SMT
(calibrated linear output) | 0.22 SMT to 2.08 SMT
(calibrated linear output) |
| Induced Electric Field at 2 cm at 1.0 SMT | 135 V/m (nominal) | 135 V/m (nominal) |
| %MT Range | 80% to 140% MT | 25% to 140% MT |
| Pulses per Second Range | 1 - 30 pps for treatment
0.1 - 0.3 pps for MT
determination | 1 - 30 pps for treatment
0.1 - 0.3 pps for MT
determination |
| Stimulation Time Range
(Pulse Train Duration) | 1 - 600 Seconds for 1 pps
1 - 20 Seconds for >1 pps | 1 - 600 Seconds for 1 pps
1 - 20 Seconds for >1 pps |
| Inter-Train Interval Range | 0 - 600 Seconds for 1 pps
10 - 60 Seconds for > 1 pps | 0 - 600 Seconds for 1 pps
10 - 60 Seconds for > 1 pps |
| Pulse Type | Biphasic Sinusoid | Biphasic Sinusoid |
| Pulse Width | 185µS (nominal) | 185µS (nominal) |
| Pulses per Treatment Session | Maximum: 5000
Nominal: 3000 | Maximum: 5000
Nominal: 3000 |
| Coil Type | Ferromagnetic, Iron Core | Ferromagnetic, Iron Core
with internal cooling fan |
| Coil Positioning System | Integrated into Head Support
System, Laser-Aided Coil
Placement | Integrated into Head Support
System, Laser-Aided Coil
Placement |
| Treatment Quality Features | Magnetic Field Level
Detection
Coil Contact Sensing | Magnetic Field Level
Detection
Coil Contact Sensing |
Table 1 Performance Specifications for NeuroStar System 3.0 and Predicate Device
Bench Performance Testing:
The following performance tests were conducted to demonstrate the substantial equivalence of NeuroStar 3.0 to the predicate NeuroStar TMS Therapy System.
- . Magnetic field mapping in 3-dimensions, spatial and temporal characteristics, and pulse sequence timing
- Coil positioning accuracy for MT, MT level and treatment location ●
6
The following additional tests were conducted to demonstrate that NeuroStar 3.0 meets performance specifications.
- NeuroStar system hardware and software unit, system and user story testing
- Usability engineering testing
- Electrical safety testing to IEC 60601-1:2005 and Electromechanical ● Compatibility (EMC) testing to IEC 60601-1-2:2007, Third Edition
Verification and validation testing demonstrated that the changes to NeuroStar 3.0 do not substantially modify the performance of the device. Therefore, differences in specifications, design, materials and manufacturing process for the NeuroStar TMS System 3.0 do not raise new questions of safety and effectiveness of the device for its indicated use. Labeling changes for NeuroStar 3.0 reflect the device changes and the labeling is otherwise the same as for the predicate device, NeuroStar TMS Therapy System (K133408/K160703).
The NeuroStar TMS Therapy System 3.0 complies with the requirements for TMS systems as defined in the FDA's "Class II Special Controls Guidance Document for Repetitive Transcranial Magnetic Stimulation (rTMS) System", dated 26 July 2011. It complies with the same medical device performance standards applied to the commercial NeuroStar System.
Based on this information, the NeuroStar TMS Therapy System 3.0 is substantially equivalent to the predicate device, NeuroStar TMS Therapy System cleared by the FDA under K133408 and K160713.
'The NeuroStar ® and NeuroStar TMS Therapy® are registered trademarks of TMS Therapy™ and NeuroStar TrakStar™ are trademarks of Neuronetics. Inc. Neuronetics, Inc.